GUEST COLUMNISTS

• March 2026 — CDMO Opportunities And Threats Report

  Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

• The Business Case For Continuous Manufacturing In Biologics

  The question for leadership is not if continuous manufacturing will transform biologics, but when and how quickly to invest.

• Mastering Biotech's Insourcing/Outsourcing Trade-Offs

  Here's a case for the biotech hybrid model, one that relies on a crack team of internal core talent complemented by broad reliance on external vendors.

• From Principles To Practice: Building Quality Into Generative AI-Assisted Pharma Operations

  Learn what regulators are already asking about AI, what quality must mean in this new context, and how organizations can begin building the governance infrastructure.

• Quantifying Single-Use Waste Produced During mAb Manufacture

  Discover the current scale of plastic single-use technology waste and its projected growth, specifically for the biomanufacturing domain. There is an increasing need for sustainable solutions.

• From QM To QMM For AI-Assisted Pharmaceutical Manufacturing Operations

  The FDA’s focus has shifted from tracking quality metrics to promoting quality management maturity. AI/ML is poised to help with efforts, though it introduces additional complexity around data integrity.

• The Systems And Choreography Needed For Grade B ATMP Material Transfer

  Traditional material air locks often fail to account for the sheer throughput needed for cell therapy workflows. These design tips help prevent traffic jams.

• Rethinking ATMP Assurance When Sterility Timelines, Reality Misalign

  The compendial 14-day sterility testing window exposes product and patient to numerous risks, but settling on a rapid alternative also presents its own set of challenges.